Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC

Официальное название

PIb/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory

Обзор

Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC

Подробное описание

Olvi-Vec is a genetic engineering modification of acne virus. GLP preclinical studies include the safety, pharmacology, and toxicology have been completed. Clinical studies exploring efficacy and safety in different types of tumor are ongoing.

Вмешательства

• Препарат Olvi-Vec
  Olvi-Vec will be administered to patient for 3 days during C1
• Препарат platinum (cisplatin or carboplatin)
  After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Platinum （Carboplatin or Cisplatin）will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.
• Препарат Etoposide
  After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Etoposide will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.

Первичные конечные точки

• Evaluate safety of Olvi-Vec in patients from day 1 to end of study [Срок оценки: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.]

Вторичные конечные точки (4)

• Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1 [Срок оценки: Day 1 to day 25 of treatment cycle 1]
• Objective Response Rate (ORR) [Срок оценки: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.]
• Disease control rate (DCR) [Срок оценки: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.]
• Progression free survival (PFS) [Срок оценки: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.]

Критерии участия

Критерии включения

• Able to understand and voluntarily sign an informed consent form.
• Age ≥ 18 years old, gender not limited.
• Small cell lung cancer confirmed by organization or cytology.
• After receiving platinum based chemotherapy regimens and/or immunotherapy, platinum based chemotherapy regimens and/or anlotinib, and other recommended treatments according to guidelines, disease progression or recurrence has occurred.
• There should be at least one measurable target lesion during the baseline period, according to RECIST 1.1 (if a lesion that has received radiation therapy has obvious evidence of disease progression after radiation therapy, it can be used as a target lesion).
• ECOG physical condition score 0 or 1.
• Have sufficient bone marrow, liver and kidney organ function-

Критерии исключения

• Compound small cell lung cancer and transformed small cell lung cancer.
• Patients with brain metastases and neurological symptoms; Note: Subjects with previous imaging evidence of brain metastases who have undergone local treatment (such as radiotherapy or surgery) for intracranial metastases and have stable lesions for more than 28 days without symptoms can be enrolled.
• Other primary malignant tumors other than small cell lung cancer (excluding non melanoma skin cancer, breast cancer in situ, cervical cancer in situ, and superficial bladder cancer, or other cancers that have been effectively controlled in the past three years and have no evidence of disease recurrence) were previously or currently combined.
• Clinically significant cardiovascular diseases At the beginning of the study treatment, the toxicity associated with previous anti-tumor treatments did not recover to ≤ CTCAE grade 1, except for hair loss and peripheral neurotoxicity of CTCAE grade 2.
• Known HIV infection (HIV antibody positive), active hepatitis B and C patients.
• Receive chemotherapy, targeted therapy, radiotherapy, and biological therapy, with less than 4 weeks since the first administration in this study; Or have received local radiotherapy within 2 weeks.
• Having undergone major surgery or significant traumatic injury within 28 days prior to the first administration of the investigational drug -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Zhejiang Provincial People's Hospital — Ханчжоу
• Shanghai chest hospital — Шанхай

Идентификаторы

NCT: NCT07136285 · Olvi-Vec-SCLC-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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